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Biotechnology
Colorado, USA-based biotech Enveda Biosciences, which is using AI to translate nature into new medicines, has announced an oversubscribed $130 million Series C funding round led by Kinnevik and FPV. 22 November 2024
Biotechnology
The landscape of atopic dermatitis (AD) treatment is advancing with approvals of oral and topical Janus kinase (JAK) inhibitors across the seven major pharmaceutical markets (7MM; USA, France, Germany, Italy, Spain, UK and Japan). 20 November 2024
Biotechnology
Johnson & Johnson and partner Protagonist Therapeutics have reported positive topline results from two Phase III studies testing a first-in-class oral peptide. 20 November 2024
Biotechnology
Aclaris Therapeutics has announced an exclusive licensing agreement with Biosion for broad rights to two new antibodies. 19 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent(dupilumab), Regeneron and partner Sanofi revealed late Friday. 18 November 2024
Pharmaceutical
Danish dermatology specialist LEO Pharma today announced that Swissmedic, Switzerland’s national regulatory agency for approving and overseeing therapeutic products, has granted marketing approval for Anzupgo (delgocitinib) cream. 14 November 2024
Biotechnology
Rubedo Life Sciences, a US biopharma developing first-in-class therapies targeting senescent cells which drive age-related diseases, has announced the appointment of Frederick C Beddingfield III, as chief executive officer and board director. 11 November 2024
Pharmaceutical
Almirall, the Spain-based biopharma, reported a 7.9% increase in net sales for the first nine months of 2024, reaching 728 million euros ($775 million), and an EBITDA rise of 2.9% to $152 million. 11 November 2024
Biotechnology
New research has been published in the Journal of Allergy and Clinical Immunology (JACI) that shows treatment with amlitelimab, an anti-OX40 ligand antibody, significantly reduced symptoms of atopic dermatitis (AD) and was maintained even after treatment stopped. 9 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
Denmark’s privately-held dermatology specialist LEO Pharma and Japan’s Kyowa Kirin have revealed that they will terminate the distribution and co-promotion agreement for the psoriasis vulgaris treatment Dovobet Ointment, Gel, and Foam (calcipotriol hydrate / betamethasone dipropionate) in Japan on December 31, 2024. 1 November 2024
Biotechnology
Regeneron Pharmaceuticals today announced financial results for the third quarter of 2024 that beat expectations, but still saw its share price fall more than 6% to $866 in early trading. 31 October 2024
Biotechnology
Treatment with Tremfya (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate plaque psoriasis (PsO) with special site involvement who had failed topical treatment, says US healthcare giant Johnson & Johnson. 25 October 2024
Biotechnology
New results show Eli Lilly Ebglyss (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with Dupixent (dupilumab). 25 October 2024
Biosimilars
Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024
Pharmaceutical
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
Biotechnology
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved a 2mL pre-filled syringe and pre-filled autoinjector, each containing 320mg of Belgian drugmaker UCB’s Bimzelx (bimekizumab-bkzx), to treat psoriasis. 14 October 2024
Biosimilars
Bio-Thera Solutions and Hungary’s Gedeon Richter have reached an exclusive commercialization and license agreement. 14 October 2024
Biotechnology
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Biotechnology
New York-based biotech firm Hoth Therapeutics has obtained exclusive worldwide licensing rights to the BioLexa Platform, an antimicrobial therapy focused on treating atopic dermatitis. 18 May 2020
Biotechnology
While targeted therapies have delivered on their promise to make oncology more personalized, the addition of immunotherapy agents without first testing for patients who are most likely to benefit may limit the success of triplet combinations in melanoma. 14 May 2020
Pharmaceutical
Switzerland-based Galderma today announced results of DREAM (Dysport Real-world Evaluation and Measured satisfaction study), a clinical study of Dysport (abobotulinumtoxinA) for Injection that evaluated patient satisfaction and safety with a twice-yearly treatment schedule. 12 May 2020
Pharmaceutical
Spanish drugmaker Almirall looked set to close trading on Monday at around 5% lower in the stock market. 11 May 2020
Biotechnology
Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb, could soon be approved in a new indication after the presentation of new data. 6 May 2020
Biotechnology
Investors in Regeneron could afford a rare smile in these difficult times, as the company’s first quarter results came in on Tuesday, sending shares 7% higher by midday. 5 May 2020
Biotechnology
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced positive top-line data from the Phase III KALM-2 study of Korsuva (CR845/difelikefalin). 21 April 2020
Pharmaceutical
Danish dermatology specialist LEO Pharma has singed a worldwide licensing deal with Taiwan-based Oneness Biotech and China’s Microbio Shanghai for the development and commercialization of the novel atopic dermatitis (AD) and allergic asthma drug candidate FB825. 15 April 2020
Pharmaceutical
While shares in Menlo Therapeutics were changing hands for near to $7 in mid-January, a Phase III failure for serlopitant, set against the wider bear market, has sent the stock to record lows. 7 April 2020
Pharmaceutical
Incyte has presented positive Phase III data for ruxolitinib cream in atopic dermatitis at a virtual symposium, called Revolutionizing Atopic Dermatitis. 6 April 2020
Pharmaceutical
Netherlands regulator the Medicines Evaluation Board (MEB) said last week that it has been informed by Danish firm LEO Parma that the production of the antibiotic Fucidin (sodium fusidate) is to be terminated for the Dutch market for business-economic reasons. This concerns the 250mg film-coated tablet (RVG 01369). 6 April 2020
Biotechnology
The pivotal Phase III clinical trial results announced today show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged six-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. 3 April 2020
Biotechnology
US biopharma firm Hoth Therapeutics today said it has entered into a non-binding letter of intent (LOI) with Isoprene Pharmaceuticals to acquire the full licensing rights of VNLG-152 novel retinamides (retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. 30 March 2020
Pharmaceutical
US pharma giant Pfizer yesterday announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. 19 March 2020
Pharmaceutical
Hot on the heels of similar action by the European Medicines Agency, the US Food and Drug Administration has completed its filing review and determined that the New Drug Application (NDA) for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis (AK), is sufficiently complete to permit a substantive review. 9 March 2020
Pharmaceutical
The European Medicines Agency will review a submission from dermatology specialist Almirall to market tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis. 2 March 2020
Pharmaceutical
A Phase II miss in chronic itching has blown a hole in Menlo Therapeutics stock, with shares losing nearly a third of their value in New York on Wednesday. 27 February 2020
Pharmaceutical
On the day that the company presented its annual financial results, Almirall has announced a license agreement for Seysara (sarecycline) in China. 24 February 2020
Pharmaceutical
The Coronavirus hit markets on Monday morning, with the uncertainty around its impact doing damage to the share prices of many pharma and biotech companies. 24 February 2020
Pharmaceutical
Last week’s news featured quite a lot relating to the ongoing novel coronavirus (COVID-19) situation, including that Sanofi’s vaccine division joining the band of drugmakers linking with the USA’s BARDA in attempts to develop a vaccine against COVID-19. Elsewhere on the research front, Incyte reported a second positive study for its Jakafi (ruxolitinib) in dermatitis, but Teva Pharmaceutical Industries posted disappointing Phase II/III results for Austedo in Tourette’s syndrome. Regulatory news included Pfizer gaining European approval for its Vyndaqel in the rare condition ATTRR-CM, and BioMarin announced the US Food and Drug Administration had accepted its gene therapy ValRox for priority review. 23 February 2020
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